A pilot study of intermediate-dose methotrexate and cytosine arabinoside, “Spread-out” or “Up-front,” in continuation therapy for childhood non-T, non-B acute lymphoblastic leukemia a pediatric oncology group study
✍ Scribed by Robert A. Krance; Edward M. Newman; Donald Pinkel; Yaddanapudi Ravindranath; Michael B. Harris; Martin Brecher; Robert Wimmer; Jonathan J. Shuster; Vita J. Land; Jeanette Pullen; William Crist
- Publisher
- John Wiley and Sons
- Year
- 1991
- Tongue
- English
- Weight
- 723 KB
- Volume
- 67
- Category
- Article
- ISSN
- 0008-543X
No coin nor oath required. For personal study only.
✦ Synopsis
One hundred six children with newly diagnosed non-T-, non-B-cell acute lymphoblastic leukemia (ALL) were treated in a Pediatric Oncology Group (POG) pilot study in which six courses of intermediate-dose methotrexate (MTX) and cytosine arabinoside (Ara-C) (1 g/m2 each) were added to a "backbone" of standard continuation therapy. The dose and sequence of MTX/Ara-C administration were based on a preclinical model that demonstrated synergism between MTX and Ara-C. Poor-risk patients (n = 49) were assigned to "up-front" therapy, in which the MTX/Ara-C courses were administered during the initial 15 weeks of remission. Standard-risk patients (n = 57) were assigned to "spread-out'' therapy, in which the MTX/Ara-C courses were interspersed at 12-week intervals within continuation treatment. Toxicity after intermediate-dose MTX/Ara-C, principally neutropenia and fever, was judged significant but manageable. Unexpectedly, the incidence of fever and neutropenia less than 500/mm3 was greater after "spread-out" therapy (38%) than after "up-front" therapy (6%). At 4 years, the Kaplan-Meier estimate of event-free survival (EFS) is 71% (k 7%) for standard-risk patients and 53% (k8Vo) for poor-risk patients. The results of this pilot study support the use of intermediate-dose MTX/Ara-C in additional studies. Cancer 67:550-556,1991.